Approach
The complexity of a project will often increase with the size of the organisation. Larger companies have more staff, a larger number of processes, a higher volume and more types of transactional documents and a larger number of silo-driven systems. These are costly to administer and prone to human error. They are, therefore, a driver of operational risk.
The root cause of high compliance risks, and associated costs, is in the way that ad-hoc systems have been set up. They are wide open to human errors, productivity issues, and time delays. SOLABS will address the key manner in which GxP information is processed, managed, and distributed. By providing a knowledge-based service approach, rather than just a software platform, implementation is facilitated. Complexity is reduced by simplifying and organizing the processes, automating their execution and enforcing their compliance. Such processes are more easily transferable to other geographical or functional sites.
Reductions in complexity and higher levels of conformity have a direct effect upon the risks and costs, as illustrated below.